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NCT05188053 · ClinicalTrials.gov registry record · Phase 4
Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 209
- Enrollment target
NCT05188053: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT05188053 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 209 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05188053, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 209 participants
- Enrollment target
Study Summary
The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
Primary Outcome
Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within
Interventions
- DRUG HTX-011
- DRUG ropivacaine , epinephrine , ketorolac diluted in sodium chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 4 |
What the finished NCT05188053 record still lists
NCT05188053 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which HTX-011 is the first listed.
NCT05188053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05188053 about?
NCT05188053 is a clinical study titled "Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty". The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with sa...
What is the current status of trial NCT05188053?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 209 participants. The study started on 2022-03-11. Estimated completion is 2024-04-18.
What interventions are being tested in trial NCT05188053?
The interventions under investigation include: HTX-011 (DRUG), ropivacaine , epinephrine , ketorolac diluted in sodium chloride (DRUG).
Who is sponsoring clinical trial NCT05188053?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05188053's enrollment target sits among peer trials
209 399th of 2000 higher than 1,602 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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